A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CROSS-OVER STUDY FOR EVALUATION OF THE EFFICIENCY AND SAFETY OF TIOTROPIUM INHALATION SOLUTION (5 µG) VIA RESPIMAT® INHALER once a day for 24 weeks for children (6 to 12 years) with bronchopulmonary dysplasia

Phase 1

Conditions: Children (6-12 years old) with bronchopulmonary dysplasia
MedDRA version: 21.1Level: PTClassification code 10006475Term: Bronchopulmonary dysplasiaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2020-000529-19-DE

Lead Sponsor: Technische Universität Dresden

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 26

Inclusion Criteria

1. the presence of bronchopulmonary dysplasia
2. formerly prematurely born male and female patients aged 6 to 12 years
3. informed consent of the guardians of the participating patients, confirmed by handwritten dating and signature, after information has been provided and the consent of the participating patients, confirmed and obtained by signature
4. FEV1 before inhalation of a betamimetic >60% and <90% of the target
5. positive bronchial reversibility test, i.e. increase of FEV1 by =12% 15-30 min after inhalation of 200 µg salbutamol
6. Ability to correctly operate the Respimat® Inhaler
7. ability to conduct the study related investigations

Are the trial subjects under 18? yes
Number of subjects for this age range: 26
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. hypersensitivity to tiotropium or its ingredients or to drugs with a similar chemical structure, as known from medical history
2. participation of the patient in another clinical trial within the last 4 weeks before inclusion
3. indications that the patient is unlikely to comply with the protocol (e.g., lack of cooperation)
4. contraindications according to the Spiriva® Respimat® technical information
5. presence of bronchial asthma
6. presence of allergic sensitization to regionally typical respiratory allergens
7. therapy with inhaled steroid within the last 4 weeks
8. therapy with short- or long-acting inhaled betamimetic within the last 4 weeks
9. therapy with leukotriene antagonists within the last 4 weeks
10. therapy with inhaled anticholinergic within the last 4 weeks
11. girls of childbearing age (defined from Tanner stage = B3)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the clinical efficacy on lung function (FEV1 peak (0-1h)) of a daily inhalation of 5 µg tiotropium via Respimat® inhaler in 6-12 year old children with bronchopulmonary dysplasia;Secondary Objective: To study the safety and effect of daily inhalation of 5 µg of tiotropium via Respimat® inhaler in 6-12 year old children with bronchopulmonary dysplasia on various lung function parameters and physical activity, measured by the Physical Activity Questionnaire for Children (PAQ-C);Primary end point(s): Change in FEV1 peak (0-1 h) after 12 weeks of treatment;Timepoint(s) of evaluation of this end point: after 12 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): AEs and SAEs<br>Change in FEV1 before inhalation after 12 weeks of treatment<br>FVC peak (0-1h) after inhalation<br>FEV1 (AUC(0-1h) and FVC (AUC(0-1h) Change<br>FEV1/FVC Change<br>MEF75-25 Change<br>FVC Change before inhalation <br>PEF am/pm Change<br>PEF Change in variability<br>Physical Activity Questionnaire for Children (PAQ-C)<br>Difference FEV1, FVC, MEF75-25 before/after standardized treadmill provocation<br>;Timepoint(s) of evaluation of this end point: after 12 weeks of treatment